Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07698093

Monitoring of Septic Shock-induced Immunosuppression

Septic syndromes are a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units (ICU). While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immune response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (cytomegalovirus (CMV) or Herpes Simplex Virus (HSV)) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. New promising therapeutic strategies are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients.

Recent studies have described the induction of immunoregulatory cells (of myeloid and lymphoid origin) following septic shock and have revealed a similar induction kinetics across all subpopulations of regulatory cells. Nevertheless, these observations need to be confirmed and linked to the underlying mechanisms responsible for the induction of these cells (notably the activation of the inflammasome pathway), which remain largely unknown.

IMMUNOSEPSIS 5 study will therefore, as part of a prospective observational study involving a large cohort of patients, demonstrate the concurrent induction of all regulatory cell subpopulations following sepsis and the activation of the hyper-inflammatory response, including the inflammasome pathway. The association between these parameters and patient outcomes will also be assessed (death and/or the occurrence of a secondary infection).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire - Groupement Hospitalier Centre, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women aged 18 years or over
  • Hospitalised patients with septic shock that began less than 48 hours prior to screening, defined by:
  • the presence of a diagnosed or suspected site of infection requiring microbiological sampling
  • the need for vasopressor therapy to maintain a mean arterial pressure ≥ 65 mm Hg
  • hyperlactataemia > 2 mmol/L (18 mg/dL) within 24 hours of the start of vasopressor therapy despite adequate fluid resuscitation (30 ml/kg).
  • A patient or relative who has been informed of the study protocol and has not objected to participating in the study

Exclusion criteria

  • Pregnant or breastfeeding women
  • People not covered by a social security scheme or similar scheme
  • Adults subject to legal guardianship (guardianship, curatorship)
  • Patients with a language barrier
  • Persons deprived of their liberty by a judicial or administrative decision
  • Subjects participating in another interventional research study involving an exclusion period that is still ongoing at the time of pre-inclusion and which, in the investigator's judgement, may interfere with this study

Treatment and study plan

Additional tubes during routine blood sample collection

Biological

Four additional tubes will be collected during the blood sample carried out as part of standard of care : a 4 mL EDTA tube, a 2.5 mL heparin tube, a 5 mL CytoChex tube and a 4 mL PAXGENE tube.These samples will be taken at inclusion, J3, J5, J15, J25 (until patient is discharged from intensive care)

Primary outcomes

  1. Study of the mechanisms regulating the immune response during septic shock, and in particular study of regulatory cell subpopulations in a large cohort of adult patients with septic shock

    Time frame: Inclusion DAY 1 (within the 48 hours of starting vasopressor therapy) Between DAY 3 and DAY 4 Between DAY 5 and DAY 7 Between DAY 15 and DAY 20 Between DAY 25 and DAY 30

    Modification of immune parameters compared with normal values in particular proportion of immunoregulatory cells

Study contacts

Contact information is provided by the study sponsor or research team.

SAUNIER Clarisse

CONTACT

[email protected]

+33 04 27 85 62 64

VENET FABIENNE, Pr

CONTACT

[email protected]

+33 4 72 11 97 46

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Immunological and Clinical Monitoring of Patients With Septic Shock in Intensive Care Unit : In-depth Immunophenotyping of Circulating Immunoregulatory Cells During Sepsis

Acronym: IMMUNOSEPSIS 5

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.